2017 Small-Cap Biotech Watchlist Update: Up 21% at the End of Q2/17

Source: Streetwise Reports (7/13/17)

If an investor had purchased an equal dollar amount of each company on The Life Sciences Report's 2017 Small-Cap Biotech Watchlist at the beginning of the year, that portfolio would show a gain of about 21% as of July. This is primarily due to the performance of a handful of companies that have been moving their assets farther down the development pipeline, according to the analysts who follow them.

Overall, as of July 12, ten Watchlist companies show gains for the first half, and the other ten show losses. Biotechs on the Watchlist for 2017 were selected by three analysts at the Biotech Showcase in January.

"Since filing an IND [investigational new drug application] for PRS-343 for patients with HER-2 positive solid tumors, the company has been engaged with the FDA to finalize the clinical trial protocol for the first-in-patient study," King noted in a July 6 research report. "Pieris will begin dosing the first patient following FDA approval of the IND."

King also noted other upcoming catalysts for the company, including the filing of "a separate clinical trial application with the German and Czech regulatory authorities to conduct a multi-dose, randomized, placebo controlled trial for PRS-080 in FID patients," and sponsoring trials for PRS-060 beginning in Q4/17 in Australia.

These developments, King stated, "mark the continued advancement of these three lead programs, with read-outs anticipated in 2018." Commented on the company's anticalin platform, King added, "Anticalins have demonstrated clinical effects in patients, and the company's current candidates continue to support potential advancement. We believe the asthma and immuno-oncology markets provide significant value to the Pieris pipeline and that management has the ability to deliver on this promising technology."

Pieris stock is currently trading at ~$6 per share.

Loxo Oncology Inc. (LOXO:NASDAQ) had posted an overall gain of ~142% over the first half of the year. In a June 5 research report, JMP Securities' King, who placed the company on the Watchlist, wrote, "Loxo Oncology announced striking data across all three ongoing clinical trials of larotrectinib (LOXO-101) in patients with tumors harboring tropomyosin receptor kinase (TRK) fusions at ASCO (the annual American Society of Clinical Oncology meeting)."

In his comments, King stated, "Given the impressive activity of larotrectinib and in a highly specific target patient population, as well as its Breakthrough Therapy Designation (BTD), we anticipate its rapid approval by the FDA with commercial launch taking place shortly thereafter in 2018."

JMP raised its target price for Loxo from $53 per share to $71. The stock currently trades at ~$76 per share.

"We believe investing in LOXO represents an investment in a modern model of the oncology drug development company," King concluded.

Abeona Therapeutics Inc. (ABEO:NASDAQ) was selected for the Biotech Watchlist by two of the analysts, Raghuram (Ram) Selvaraju of Rodman&Renshaw, and George Zavoico of JonesTrading Institutional Services. Abeona stock has logged an ~80% increase since the first of the year.

Commented on the company's Q1/17 results in a May 17 research report, Selvaraju noted that Abeona's "cash position remains strong." The analyst also made note of a number of catalysts, some that have been achieved, and some that can be anticipated.

"Abeona's most advanced candidate, has been accorded Fast Track designation from the FDA as well as Orphan Drug designation in both the U.S. and Europe," Selvaraju stated. "This program in Sanfilippo Syndrome A (MPS IIIA) would be eligible for a Priority Review Voucher (PRV) as well. Abeona has secured Orphan Drug designation in the European Union for its second pipeline candidate, ABO-101, for MPS IIIB and for ABO-201 in Juvenile Batten Disease. ABO-201 could enter the clinic early next year." In addition, the company's "epidermolysis bullosa program remains on track with incremental positive data presented."

Selected for the Watchlist by King, in a June 5 research report the analyst commented on the company's recent announcement of "positive updated data from its ongoing Phase I clinical trial of BLU-285 in advanced gastrointestinal stromal tumor (GIST) and plans to pursue expedited development in patients with a PDGFRα D842V mutation." King also noted that Bluesprint has announced FDA approval of breakthrough therapy designation for BLU-285, and "plans to pursue expedited development of BLU-285 in this patient population."

Reflecting on the company's "products, platform [and] personnel," King wrote, "Blueprint Medicines brings all of the elements together for a highly successful and sustainable discovery-based biotechnology company that will benefit patients with its compounds and investors with returns on its shares. We remain confident that BPMC shares will accrete as we are presented with compelling data from the company's trials of BLU-258 and BLU-554. In anticipation of the success with BPMC's two lead programs, we believe investors will also attribute a higher likelihood of success to the company's pipeline prospects."

In a June 5 research report, JMP's King, who placed this company on the Watchlist, commented on progress on its Phase 1b/2 ENCORE 601 trial "investigating the combination of entinostat, the company's lead asset and selective HDAC inhibitor, plus Keytruda (pembrolizumab [MRK, NC]), an anti-PD-1 antibody, in patients with melanoma, NSCLC (non-small cell lung cancer), and microsatellite stable colorectal cancer."

JMP believes "Syndax represents a rare investment opportunity in the small cap oncology space." King also noted that "entinostat [has] already demonstrated a meaningful benefit in both progression-free and overall survival in a large tumor category (metastatic breast cancer). In addition to its demonstrated clinical benefit, entinostat has also received breakthrough therapy designation (BTD) from the FDA. . .With such a robust asset under development, we believe Syndax could potentially clear regulatory hurdles to rapidly translate its preclinical and clinical success with entinostat into a marketed therapy."

Want to read more Life Sciences Report articles like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see recent articles and interviews with industry analysts and commentators, visit our Streetwise Interviews page.

Disclosure:
1) Tracy Salcedo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in this article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following company mentioned in this article is a billboard sponsor of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article, until one week after the publication of the interview or article.

Analyst Certification: The research analyst(s) who prepared this report does/do hereby certify that the views presented in this report are in accordance with my/our personal views on the securities and issuers discussed in this report. As mandated by SEC Regulation AC no part of my/our compensation was, is or will be directly or indirectly related to the specific views or recommendations expressed herein. This certification is made under the obligations set forth in SEC Regulation AC. Any other person or entity may not use it for any other purpose. This certification is made based on my/our analysis on the date of this report’s publication. I/We assume no obligation to update this certification to reflect any facts, circumstances or events that may subsequently come to my/our attention. Signed Michael G. King

JMP Securities Disclosures:

JMP Securities currently makes a market in the security of Syndax Pharmaceuticals, Inc.

JMP Securities expects to receive OR intends to seek compensation for investment banking services from Syndax Pharmaceuticals, Inc. in the next 3 months.

JMP Securities LLC, its affiliates, JMP Group LLC, Harvest Capital Strategies LLC, and their respective partners, directors, officers, and associates may have a long or short position in, may act as a market maker for, or may purchase or sell a position in the securities mentioned herein. JMP Securities LLC or its affiliates may be performing, have performed, or seek to perform investment banking, advisory, or other services and may have acted as manager or co-manager for a public offering of securities for any company mentioned herein. The reader should assume that JMP Securities LLC will solicit business from the company covered in this report.

Analyst Certification: The research analyst(s) who prepared this report does/do hereby certify that the views presented in this report are in accordance with my/our personal views on the securities and issuers discussed in this report. As mandated by SEC Regulation AC no part of my/our compensation was, is or will be directly or indirectly related to the specific views or recommendations expressed herein. This certification is made under the obligations set forth in SEC Regulation AC. Any other person or entity may not use it for any other purpose. This certification is made based on my/our analysis on the date of this report’s publication. I/We assume no obligation to update this certification to reflect any facts, circumstances or events that may subsequently come to my/our attention. Signed Michael G. King

JMP Securities Disclosures:

JMP Securities currently makes a market in the security of Blueprint Medicines Corp

JMP Securities was manager or co-manager of a public offering of securities for Blueprint Medicines Corp (BPMC) in the past 12 months, and received compensation for doing so.

JMP Securities expects to receive OR intends to seek compensation for investment banking services from Blueprint Medicines Corp in the next 3 months.

JMP Securities LLC, its affiliates, JMP Group LLC, Harvest Capital Strategies LLC, and their respective partners, directors, officers, and associates may have a long or short position in, may act as a market maker for, or may purchase or sell a position in the securities mentioned herein. JMP Securities LLC or its affiliates may be performing, have performed, or seek to perform investment banking, advisory, or other services and may have acted as manager or co-manager for a public offering of securities for any company mentioned herein. The reader should assume that JMP Securities LLC will solicit business from the company covered in this report.

Analyst Certification: The research analyst(s) who prepared this report does/do hereby certify that the views presented in this report are in accordance with my/our personal views on the securities and issuers discussed in this report. As mandated by SEC Regulation AC no part of my/our compensation was, is or will be directly or indirectly related to the specific views or recommendations expressed herein. This certification is made under the obligations set forth in SEC Regulation AC. Any other person or entity may not use it for any other purpose. This certification is made based on my/our analysis on the date of this report’s publication. I/We assume no obligation to update this certification to reflect any facts, circumstances or events that may subsequently come to my/our attention. Signed Michael G. King

JMP Securities Disclosures:

JMP Securities currently makes a market in the security of Pieris Pharmaceuticals, Inc.

JMP Securities expects to receive OR intends to seek compensation for investment banking services from Pieris Pharmaceuticals, Inc. in the next 3 months.

JMP Securities LLC, its affiliates, JMP Group LLC, Harvest Capital Strategies LLC, and their respective partners, directors, officers, and associates may have a long or short position in, may act as a market maker for, or may purchase or sell a position in the securities mentioned herein. JMP Securities LLC or its affiliates may be performing, have performed, or seek to perform investment banking, advisory, or other services and may have acted as manager or co-manager for a public offering of securities for any company mentioned herein. The reader should assume that JMP Securities LLC will solicit business from the company covered in this report.

Analyst Certification: The research analyst(s) who prepared this report does/do hereby certify that the views presented in this report are in accordance with my/our personal views on the securities and issuers discussed in this report. As mandated by SEC Regulation AC no part of my/our compensation was, is or will be directly or indirectly related to the specific views or recommendations expressed herein. This certification is made under the obligations set forth in SEC Regulation AC. Any other person or entity may not use it for any other purpose. This certification is made based on my/our analysis on the date of this report’s publication. I/We assume no obligation to update this certification to reflect any facts, circumstances or events that may subsequently come to my/our attention. Signed Michael G. King

JMP Securities Disclosures:

JMP Securities currently makes a market in the security of Loxo Oncology, Inc.

JMP Securities expects to receive OR intends to seek compensation for investment banking services from Loxo Oncology, Inc. in the next 3 months.

JMP Securities LLC, its affiliates, JMP Group LLC, Harvest Capital Strategies LLC, and their respective partners, directors, officers, and associates may have a long or short position in, may act as a market maker for, or may purchase or sell a position in the securities mentioned herein. JMP Securities LLC or its affiliates may be performing, have performed, or seek to perform investment banking, advisory, or other services and may have acted as manager or co-manager for a public offering of securities for any company mentioned herein. The reader should assume that JMP Securities LLC will solicit business from the company covered in this report.

I, Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Abeona Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2017 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Abeona Therapeutics, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did receive compensation from Abeona Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Abeona Therapeutics, Inc. as of the date of this research report.

A small-cap biotech focused on developing customized treatments for cancer patients has earned inclusion on the NASDAQ Biotechnology Index, as well as caught the eye of analyst Michael King of JMP Securities.